Optetrak Logic 02-012-65-2011Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885862265876), received between Mar 23, 2023 and Mar 23, 2023 — classified as 1 injury.

1 FDA recall record name this device's identifier, 1 still open.

4 other recalls cover devices cleared under the same FDA submission (K150890); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Aug 30, 2021Open, Classified

   Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

   Z-0021-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 73 YO FEMALE PATIENT EXPERIENCED PATELLAR TENDINITIS OF THE RIGHT KNEE, ESPECIALLY WHEN GOING UP AND DOWN THE STAIRS (ANTERIOR KNEE PAIN). THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2017. THE PATIENT WAS TREATED WITH EXERCISE MODIFICATION AND PRP INJECTION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING.

  Patient problems: Pain

  MAUDE report 16602828 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150890. One submission often covers many models, so check the product and lot details in each record.

• Z-0583-2024 · Nov 21, 2023 · Open, Classified
  Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
• Z-1364-2020 · Jan 27, 2020 · Open, Classified
  Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femoral components, tibial inserts, s
• Z-3209-2018 · May 8, 2018 · Open, Classified
  Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total k
• Z-2704-2017 · Apr 7, 2017 · Terminated
  Exactech Optetrak Logic CC 15mm Tibial Augment Screws